Not correcting thrombocytopenia prior to CVC placement in patients is non-inferior compared to correcting thrombocytopenia.
ID
Bron
Verkorte titel
Aandoening
Central venous catheter, CVC, centraal veneuze lijn, coagulopathy, coagulopathie, platelet count, thrombocytopenia, trombocytopenie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
A procedure-related relevant bleeding, occurring within 24 hours after the procedure. A WHO grade 2-4 (appendix I) up to 24 hours of randomization is defined as relevant bleeding. Secondary study parameters/endpoints (if applicable)
Achtergrond van het onderzoek
Critically ill and hematologic patients undergoing therapy need a central venous catheter (CVC). These patients often suffer from thrombocytopenia at the moment of CVC placement. The current national and international guidelines support correction of thrombocytopenia up to a platelet count of 50 x 109/L prior CVC placement. There is, however, no evidence to support correction of thrombocytopenia. On the other hand it has been proven that transfusion of platelets concentrates (PC) can be complicated by serious side effects. Furthermore, transfusion of PC is expensive. Retrospective studies suggest it is safe to place CVC independent of the platelet count down to 10 x 109/L. Our objective is to determine whether not correcting thrombocytopenia prior to CVC placement is non-inferior compared to correcting thrombocytopenia, in a controlled setting.
Doel van het onderzoek
Not correcting thrombocytopenia prior to CVC placement in patients is non-inferior compared to correcting thrombocytopenia.
Onderzoeksopzet
Directly after CVC insertion, 1 hour, 24 hours.
Onderzoeksproduct en/of interventie
Eligible patients will be randomly assigned to either receiving one unit of platelet concentrate, or no platelet concentrate. There will be no placebo treatment. Rescue platelet concentrate will be available for administration at clinicians’ discretion. Blinding for the outcome will be performed for the researcher, not for the physicians and patients.
Publiek
Meibergdreef 9
A.P.J. Vlaar
Amsterdam 1105 AZ
The Netherlands
-
a.p.vlaar@amc.uva.nl
Wetenschappelijk
Meibergdreef 9
A.P.J. Vlaar
Amsterdam 1105 AZ
The Netherlands
-
a.p.vlaar@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age>18 years
2. Need for CVC placement at the clinician’s discretion
3. Platelet count between 10–50x109/L
4. INR<3.0
5. Informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Use of therapeutic anticoagulant therapy, except single antiplatelet therapy
2. Contra-indication for PC transfusion, such as Thrombotic thrombocytopenic purpura, or Congenital IgA deficiency
3. Randomization in the previous 24 hours
4. Patients with a history of congenital or acquired coagulation factor deficiency or bleeding diathesis
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5534 |
| NTR-old | NTR5653 |
| Ander register | 843002625, ZonMW : 2015_278, METC AMC |